Testing Digital Breast Tomosynthesis vs. Regular Mammogram in Detecting Breast Cancer in Women Having Screening Mammogram

To compare DBT and FFDM for screening effectiveness in women who present for screening mammography with respect to screening recall rate.

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Key information

Conditions

Breast Cancer Antisocial Personality Disorder Breast Diseases Breast Neoplasms Mental Disorders Neoplasms Neoplasms by Site Personality Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

GE Healthcare

Princeton, New Jersey, 08844, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women ≥18 years or older for screening mammography
Able and willing to comply with study procedures, and have signed and dated the informed consent form
The subject is surgically sterile or postmenopausal

Exclusion criteria

Pregnant or trying to become pregnant
Has signs or symptoms of breast cancer
Has been previously included in this study
Has breast implants
Has a history of breast cancer and is in active treatment
Has breasts too large to be adequately positioned for the DBT examination

Treatment and study plan

Primary outcomes

Compare the diagnostic performance of FFDM and DBT in detecting and excluding breast cancer in asymptomatic women.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 1. Women Undergoing Screening Mammography

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Sep 26, 2007
Registry last updated: May 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed